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25 Medical Societies Petition JAMA to Retract Testosterone Study

May 13, 2014

25 Medical Societies Petition JAMA to Retract Testosterone StudyTwenty-five medical societies, including the Sexual Medicine Society of North America, have petitioned the Journal of the American Medical Association (JAMA) to retract a controversial study on testosterone therapy.

The study, published in the November 13, 2013 issue of JAMA, was conducted by a research team from the University of Colorado.  It suggested that a particular group of men on testosterone therapy were at greater risk for stroke, heart attack, and death. The research was one of two studies that prompted the U.S. Food and Drug Administration (FDA) to re-evaluate FDA-approved testosterone products.

However, a group of experts in urology, endocrinology, and andrology say that there was “gross data mismanagement” in the study and that the findings are “no longer credible,” according to a press release from the Androgen Study Group, which submitted the petition in March.

Since the study’s first appearance in JAMA, the journal has published two corrections. The first addressed a misrepresentation of raw data as statistical estimates and was not published until January 2014.

The second correction, published in March, concerned classification of patients in the study. For example, 10% of the participants were women, but the study was supposed to involve men only.

“This article has caused enormous damage,” said Dr. Mohit Khera, Associate Professor of Urology at Baylor Medical College, in the press release. “This article created an unfounded negative perception of testosterone therapy. Physicians discontinued treatment for men who were benefitting from treatment. It harmed physician-patient relations, as patients ask why their physicians placed their health at risk. And a new field of medical malpractice has sprung up overnight, with plaintiff attorneys in the US advertising nationwide for patients who suffered a stroke or heart attack after receiving testosterone. And it’s all based on pure nonsense.”

According to reports from MedPage Today and The Wall Street Journal, the study authors “stand firmly” by their results and note that the reclassification of patients did not change the study’s findings.

On March 25, 2014, The Wall Street Journal reported that JAMA did not plan to retract the study.


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Resources

Androgen Study Group

“Twenty-Five Medical Societies Join Androgen Study Group to Petition JAMA to Retract Misleading Testosterone Study”

(Press release. April 10, 2014)

http://www.androgenstudygroup.org/press-releases/92-2014-04-10

MedPage Today

Fiore, Kristina

“Group Wants Testosterone Study Retracted”

(March 26, 2014)

http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44952

U.S. Food and Drug Administration

“FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products”

(Safety Announcement. January 31, 2014)

http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?utm_source=rss&utm_medium=rss&utm_campaign=fda-evaluating-risk-of-stroke-heart-attack-and-death-with-fda-approved-testosterone-products

The Wall Street Journal

Silverman, Ed

“A High Stakes Battle Over Testosterone”

(March 25, 2014)

http://blogs.wsj.com/corporate-intelligence/2014/03/25/a-high-stakes-battle-over-testosterone/